Accelerating Decentralised Clinical Trials: Technology Imperatives...
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Accelerating Decentralised Clinical Trials: Technology Imperatives for CROs

Pharma Tech Outlook | Monday, May 08, 2023

The unprecedented global scenario due to COVID-19 has promptly accentuated decentralised clinical trials (DCTs) in medical research. Interestingly, public health concerns and travel restrictions helped contract research organisations (CROs) in fostering novel and transformative ideas in conducting clinical studies.

Decentralised clinical trials (DCTs) have become increasingly important in medical research as a result of the unique worldwide situation brought on by COVID-19. Interestingly, contract research organisations (CROs) were able to nurture innovative and game-changing concepts for carrying out clinical investigations because of public health concerns and travel restrictions. The CROs are constantly seeking ways to speed up data-driven insights through safe techniques and optimise research time. Here are some of the technological approaches that could help CROs perform decentralised clinical trials effectively and produce data-driven insights more quickly.

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Decentralised clinical trials: A transformed way of clinical studies

Clinical trials that require sophisticated techniques, such as cell culture, bioanalytical research, or an MRI, must be carried out at a research facility. However, a drug or medication can be given locally in less complicated studies. In decentralised clinical trials, the subject (patient) receives medication at a nearby location while having their body vitals tracked and documented remotely or using wearable technology. Hybrid and decentralised studies can be performed at many locations, though not all are entirely virtual. A decentralised clinical trial is a novel approach that primarily focuses on the potency of its technology. The CROs should concentrate on creating a strong technological foundation. To maximise the potential of DCT, a secure and modern technology platform providing interoperability is necessary.

Building for the Future – A scalable, adaptive, and agile enterprise architecture

The reality of CROs includes electronic data collection, connected devices, and large-scale data processing. In contrast, CROs are also referred to as data firms. The connected devices will need to be able to store and process data locally due to the enormous rate at which data will be created. Therefore, these organisations' enterprise architecture needs to be flexible and scalable to accommodate all such future needs and trends.

Real-time, sophisticated data analytics are made possible by edge computing. Organisations must collaborate with numerous regional labs and sites to use DCTs. These facilities and venues may use many types of IT infrastructure. To meet these demands, organisations must invest in developing an agile corporate architecture. The following summarises some crucial technological and business architectural considerations:

• Revitalised Core: Modernising the core necessitates a horizontal, end-to-end strategy. A robust foundation at the backend is necessary for the success of new technologies used for real-time data processing, sophisticated analytics, ML, automation, low-code, hyperconnectivity, etc.

• Composable business architecture: There is a high demand for API-led system integrations with event-driven security built in.

• Governance framework: The breadth and complexity of IT governance are unavoidably broad in this environment. Modern monitoring and support solutions are needed since many IoT devices are dispersed around the globe, there are hyperconnected systems, and agile software development is used.

• Advanced analytics: Clinical research is fundamentally based on analytics. Predictive and exploratory analytics, data and text mining, and advanced data platforms with AI capabilities assist in generating meaningful results in real time and shorten the total research cycle.

‘Zero-trust’ Cyber Security

The governance of patient healthcare data is subject to tight rules set by federal authorities throughout the majority of the world. As a result, CROs are heavily responsible for data security. The enterprise architecture of the company is built for greater scalability, which comes with the inherent issue of managing more vulnerabilities. A secure-by-design policy for the organisation must be created by a committed and varied group of security professionals. It is crucial to have an integrated and complete approach to protecting the organisation's data.

Accomplishing Desired Results

Decentralised clinical trial models require a solid technological underpinning. These studies focus on the patient, are open to everyone, and increase testing variety. DCTs speed up the process of introducing fresh pharmaceuticals to the market. The technology used carefully can help to achieve desired outcomes.

When compared to conventional trials, the DCT model offers sponsors and patients several advantages. While sponsors may experience accelerated recruitment (in a market where competition for patients is growing), increased patient engagement and retention, a broader and more diverse patient population, time and cost savings, and seamless multisite management, patients benefit from convenience, reduced travel burden, and increased trial access. Before starting a DCT, it is important to think about who will support and manage the trial's technologies, whether any special protocol modifications are necessary to ensure compliance, who will manage source documents at decentralised sites, and what specifications will apply to any trial-specific procedures.

The majority of trials can benefit from virtualiSing one or more trial components, even if DCTs may not be appropriate for all trial designs. Sponsors are strongly urged to become familiar with the various DCT models available, including their benefits and drawbacks, before starting a DCT. In the end, the study protocol's structure and if HCP visits are required will determine which model is used.

Trials that utilise a mix of virtual approaches and in-person site visits are also options among the models. Since completely virtual trials are conducted off-site and utilise virtual means for all activities, including consent, they are more suitable for trials with simple visits and procedures. In contrast, DCTs that offer a combination of in-person visits to the clinical location or the patient's home for protocols that call for in-person interaction (such as when challenging treatments are required) are becoming more popular.

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